Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) announced the first patient was dosed in December 2025 in its global Phase 3 program evaluating YCANTH (VP-102) for common warts.

The Phase 3 start follows positive Phase 2 COVE-1 topline results where 51% (18 of 35) of subjects in Cohort 2 achieved complete clearance at Day 84; adverse events were primarily local cutaneous reactions with no SAEs observed. Verrica retains global rights to YCANTH outside Japan.

Torii will split Phase 3 costs 50/50, funding the first $40 million (about 90% of the current trial budget); Verrica recently completed a $50 million financing and repaid its OrbiMed debt facility. Verrica cites a U.S. prevalence of ~22 million patients and no FDA‑approved therapies for common warts.

Positive

• Phase 3 initiation with first patient dosed in December 2025
• Phase 2 COVE-1 showed 51% complete clearance (18 of 35) at Day 84
• Torii to fund $40 million of initial trial costs (~90% of budget)
• Completed $50 million financing and repaid OrbiMed debt facility
• Verrica retains global rights to YCANTH outside Japan

Negative

• COVE-1 Phase 2 Cohort 2 was open-label with a small sample (35 subjects)
• Verrica’s Phase 3 portion is expected to be paid from future Japan milestones/royalties

Key Figures

Subjects complete clearance 51% (18 of 35) COVE-1 Phase 2, Cohort 2, Day 84 complete clearance of treatable warts

Follow-up duration Day 84–147 Primary analysis at Day 84 with follow-up through Day 147 in COVE-1

Warts per subject cap Up to 6 warts Eligibility in COVE-1 Phase 2 common wart trial

Trial cost funding $40 million Torii funds first $40M of global Phase 3 common-wart trial costs

US prevalence 22 million patients Estimated common-wart prevalence in the United States

Recent financing $50 million Completed financing referenced to support growth and debt repayment

Pediatric share 50% of treated patients Portion of treated US common-wart patients who are children

Trial budget coverage 90% of current budget Torii’s $40M commitment approximates 90% of Phase 3 trial budget

Market Reality Check

$7.95 Last Close

Volume Volume 199,201 is in line with 20-day average of 198,824, showing no unusual trading activity. normal

Technical Shares at $8.05 are trading above the 200-day MA of $5.66, despite a -9.24% move in the prior session and sitting 18.03% below the 52-week high.

Peers on Argus

VRCA fell 9.24% in the prior session, while peers PSTV, GRCE, CALC, OTLK, and RADX showed smaller single-day declines between about -0.55% and -4.67%, suggesting more stock-specific pressure rather than a strong sector-wide move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Financing / balance sheet	Positive	+12.1%	Private placement to raise $50M, retire OrbiMed debt, extend cash runway.
Nov 14	Quarterly earnings update	Positive	-5.1%	Q3 2025 revenue growth and near-break-even results with YCANTH momentum.
Nov 10	VP-315 Phase 2 data	Positive	+11.8%	Strong BCC efficacy and safety data with FDA End-of-Phase 2 agreement.
Oct 20	EMA regulatory update	Positive	+8.0%	EMA advice supports YCANTH MAA in EU with no new Phase 3 required.
Oct 07	Conference presentation notice	Neutral	-1.7%	Planned VP-315 Phase 2 BCC data presentations at SITC 2025 meeting.

Pattern Detected

VRCA has often traded higher on positive clinical/regulatory catalysts, while financing and earnings-related news have produced mixed reactions, including at least one divergence where seemingly constructive financial updates coincided with a share-price decline.

Recent Company History

Over the last few months, Verrica reported multiple clinical and regulatory milestones alongside balance-sheet actions. In Jan 2025, VP-315 Phase 2 data in BCC showed a 97% objective response rate and 51% complete histologic clearance. Subsequent clinical-trial and EMA feedback updates through Oct–Nov 2025 generally coincided with positive price moves. In Nov 2025, Q3 results and a $50M private placement to retire OrbiMed debt extended cash runway, though the earnings release saw a modest share-price pullback despite solid YCANTH revenue growth.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-12-15

An effective S-3 shelf registration filed on Dec 15, 2025 covers up to 14,756,230 shares of common stock for resale by existing stockholders. Verrica will not receive proceeds from these resales but would receive cash only if pre-funded warrants and common warrants are exercised at their stated prices of $0.0001 and $6.315 per share, respectively. The filing also reiterates auditors’ prior note of substantial doubt about the company’s ability to continue as a going concern.

Market Pulse Summary

This announcement highlights progression of YCANTH into a global Phase 3 program for common warts, leveraging Phase 2 COVE-1 data where 51% of subjects in one cohort achieved complete clearance by Day 84 with no reported SAEs. The addressable U.S. population of about 22 million patients, half of whom are children, underscores the unmet need. Investors may monitor Phase 3 enrollment progress, Torii’s commitment to fund up to $40M of costs, and future updates on regulatory pathways and commercialization plans.

Key Terms

phase 3 medical

"first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

"clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

primary endpoint medical

"clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

open label medical

"COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102"

Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.

adverse events medical

"Adverse events were primarily expected local cutaneous reactions with no SAEs observed"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

cohort medical

"18 of 35 treated with VP-102 in Cohort 2 achieved complete clearance"

A cohort is a group of people, customers, or study participants who share a specific characteristic or experience within a defined time frame—for example, patients given the same treatment or customers who started using a service in the same month. Investors use cohort analysis to track performance, revenue patterns, or risks over time, much like comparing different batches of a product to see which approaches produce lasting results.

topline analysis medical

"Topline analysis included data from the assessment of warts at study visits over 12 weeks"

A topline analysis is a high-level review of a company's most important headline numbers—typically sales (revenue), profit margins and other primary results—meant to show whether the business is growing or shrinking. It matters to investors because it provides a quick snapshot of performance and momentum, helping decide whether to investigate further or adjust valuations, much like glancing at a car’s speedometer to judge whether you need to slow down or speed up.

AI-generated analysis. Not financial advice.

– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for what is believed to be a multibillion-dollar market opportunity–

– Verrica has global rights to YCANTH for all indications in all territories outside of Japan –

WEST CHESTER, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that the first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts.

“The dosing of the first patient in the global Phase 3 program in common warts represents an important clinical milestone for our label expansion strategy of YCANTH,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “The clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study provides strong evidence that YCANTH has the potential to become the first therapy ever approved in both the United States and Japan for the treatment of common warts – a condition that impacts over 22 million people in the U.S. alone. Having retained full commercial rights for all potential YCANTH indications outside of Japan, common warts represents a substantial commercial and licensing opportunity for our company. Coupled with our recently completed $50 million financing and repayment of our debt facility with OrbiMed, this significant clinical milestone is another key step towards the expansion of the YCANTH franchise and the future growth of Verrica.”

COVE-1 Phase 2 Data and Phase 3 Program in Common Warts

The initiation of the global Phase 3 program in common warts is based upon positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts. COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary efficacy analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed that 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Adverse events were primarily expected local cutaneous reactions with no SAEs observed. Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget, with Verrica’s portion expected to be paid out of future milestones/royalties for YCANTH in Japan.

Market Opportunity in Common Warts

With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children. If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, Verrica anticipates a high degree of call point overlap and marketing synergies with its promotion of YCANTH for the treatment of molluscum. Verrica further believes that the common wart patient opportunity in the European Union is comparable to that in the United States.

About YCANTH^® (VP-102)
YCANTH^® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. Approximately 250 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Please visit YCANTHPro.com for additional information.

About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH^® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH^® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the commercialization of YCANTH, clinical development, clinical timelines and potential benefits of YCANTH for the treatment of common warts, These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

John Kirby
Interim Chief Financial Officer
jkirby@verrica.com

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

FAQ

When was the first patient dosed in Verrica's Phase 3 program for common warts (VRCA)?

The first patient was dosed in December 2025 in the global Phase 3 program.

What were the Phase 2 COVE-1 topline results for YCANTH (VP-102) in common warts?

In Cohort 2, 51% (18 of 35) of subjects achieved complete clearance of treatable warts at Day 84; adverse events were mainly local reactions and no SAEs were observed.

How is the Phase 3 trial for YCANTH being funded and what is Verrica's financial role (VRCA)?

Torii will split costs 50/50, funding the first $40 million (~90% of current trial budget); Verrica’s share is expected to be paid from future Japan milestones/royalties.

Does Verrica hold commercial rights for YCANTH outside Japan (VRCA)?

Yes, Verrica retains global rights to YCANTH for all indications in all territories outside of Japan.

What recent corporate financing did Verrica complete ahead of the Phase 3 start (VRCA)?

Verrica recently completed a $50 million financing and repaid its debt facility with OrbiMed.

How large is the U.S. market opportunity for common warts cited by Verrica (VRCA)?

Verrica cites approximately 22 million patients in the U.S. and notes there are currently no FDA‑approved prescription therapies for common warts.